Principles of classification

The principles of classification as a medicine

According to the Medicines Act 6 §, Fimea is the competent authority to decide, if necessary, whether a substance or preparation is classified as a medicine. The classification is done on a product-by-product basis based on an evaluation of the composition and purpose of use. In addition to the information provided by the applicant, the classification is based on the information presented in the product's marketing and information based on scientific literature about the effects of the product's ingredients. When making decisions, the jurisprudence of the EU Court is taken into account.

Fimea evaluates all the characteristics of the product, which include, among other things, their composition, medically established, known pharmacological properties as they can be established in the light of current scientific knowledge, the ways of use, the extent of its distribution, the knowledge that consumers have about the product in question, and the dangers that usage can be monitored.

Why is figuring out the classification important?

It is important to find out the product classification of the preparation, because different legislation applies to different preparations, for example in terms of import, sales and marketing and distribution channels.

Private persons should make sure of the product's category in advance, i.e. before ordering a product from, for example, an online store from abroad for his own use. The trader should  make sure in advance that the import or manufacture and sale of the product has been carried out in accordance with the requirements of the correct legislation. Preparations of different product categories fall under the jurisdiction of different supervisory authorities.

If it is uncertain whether the product is a medicine or a food supplement, a cosmetic product, a biocide or a CE-marked medical device, the product must be classified by Fimea.

In that case, the composition of the product and the mechanisms of action of the ingredients should be evaluated in relation to the marketing claims and dosage. The importer or manufacturer is recommended to confirm the class of their product before bringing it to the market.

The classification process takes about 1–6 months and the decision is subject to a fee.

Fimea makes about 3-5 individual classification decisions every year.

Updated May 19, 2023.